BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL CATH LAB SET

    MDR report key: 1203288 · Received October 14, 2008

    Report

    Report Number
    9616567-2008-00097
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Report Date
    September 15, 2008
    Manufacturer
    SMITHS MEDICAL, ASD.
    Product Code
    DRS
    PMA / PMN Number
    K820355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE WAS RECEIVED WITH NO PHYSICAL DAMAGE OR MFG ISSUE FOUND IN THE WALL SECTION SEPARATING THE AIR VENT AND FLUID PATHWAY THAT WOULD HAVE CONTRIBUTED TO AIR ENTRAPMENT. THE FLUID PATHWAY AND AIR VENT WERE CLEAR DURING TESTING WITH NO BLOCKAGE FOUND. WITH THE TUBING CLAMPED OFF AND THE FLUID PATH FILLED WITH WATER, AIR WAS APPLIED TO THE AIR VENT TO CHECK FOR AIR ENTERING THE WATER COLUMN. NO AIR ENTERED THE WATER COLUMN DURING TESTING. THE DEVICE HISTORY WAS REVIEWED WITH NO ISSUES NOTED. SMITHS WAS UNABLE TO CONFIRM THE ISSUE. A POSSIBLE CAUSE WOULD BE INCORRECT PRIMING. INSERTING THE SPIKE HORIZONTALLY CAN ALLOW AIR FROM THE VENT TO BE PULLED INTO THE FLUID LINE DURING PRIMING. PRIMING INSTRUCTIONS STATE THAT THE SPIKE MUST BE IN A VERTICAL POSITION. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THERE WAS AIR ENTRAPMENT IN THE DYE LINE DURING PROCEDURE SET-UP. THE MANIFOLD WAS DISCARDED PRIOR TO PT USE, SO THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL CATH LAB SET PRESSURE MONITORING SET DRS SMITHS MEDICAL, ASD. NA 1320566

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK